6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of November, 2024

Commission File No. 001-39621

OPTHEA LIMITED

(Translation of registrant’s name into English)

Level 4

650 Chapel Street

South Yarra, Victoria, 3141

Australia

(Address of registrant’s principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

EXHIBIT INDEX

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.

Date: 11/26/2024

EX-99.1

Exhibit 99.1

ASX, Nasdaq and Media Release

November 26, 2024

Opthea’s Wet AMD Program to be Featured at FLORetina 2024

Melbourne, Australia, and Princeton, NJ, US, November 26, 2024 -- Opthea Limited (ASX/NASDAQ:OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that sozinibercept will be featured as part of an oral presentation at the annual FLORetina Congress being held on December 5-8, 2024 in Florence, Italy. FLORetina aims to provide cutting-edge insights on research and clinical development from world-leading experts in the field of medical retina, retinal surgery, and imaging.

Details are as follows:

Session: Retina Futura 1: Wet Age-Related Macular Degeneration (wAMD): Emerging Therapies and Clinical Updates

Date: Friday, December 6, 2024, 11:25 AM CET

Presentation: Beyond VEGF-A Inhibition: Will Blocking VEGF-C and VEGF-D Lead to Better Outcomes?

Presenter: Professor Adnan Tufail, MBBS, MD, FRCOphth

Program: https://floretina.com/floretinaicoormeeting2024/program

About Opthea

Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet needs in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

Opthea’s lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A therapies to improve the overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents alone.

To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn.

Authorized for release to ASX by Frederic Guerard, PharmD, CEO